CMB Collegium Medicum Berlin GmbH, Berlin, Germany.
MVZ Dermatologisches Zentrum Bonn GmbH, Bonn, Germany.
J Am Acad Dermatol. 2021 Dec;85(6):1510-1519. doi: 10.1016/j.jaad.2021.03.031. Epub 2021 Mar 17.
Actinic keratoses (AK) may occur in all sun-exposed skin areas. Those occurring outside the head area are generally more resistant to treatment than those on the face.
To determine efficacy and safety of BF-200 ALA versus vehicle in the treatment of mild-to-severe AK located on extremities, trunk, and neck with red light photodynamic therapy (PDT).
This phase III study had an intra-individual design with 50 patients in 6 centers in Germany. Each patient received a maximum of 2 field-directed PDTs. Clinical end points and 1-year follow-up results were recorded.
BF-200 ALA was superior to the vehicle with respect to total lesion clearance rates (86.0% vs 32.9%; P < .0001) and patient complete clearance per patient's side (67.3% vs 12.2%, P < .0001). One-year overall lesion recurrence rate was 14.1% versus 27.4% (BF-200 ALA vs vehicle; P = .0068). Patients were more satisfied by the cosmetic outcome of BF-200 ALA/PDT than the vehicle/PDT. Adverse events were consistent with the known safety profile of BF-200 ALA/PDT.
Small number of severe lesions; limited sample size; unbalanced but representative distribution of AK.
BF-200 ALA showed significantly higher AK clearance rates on extremities, trunk, and neck than the vehicle and was well tolerated.
光化性角化病（AK）可发生于所有暴露于阳光的皮肤区域。发生于头面部以外的皮损通常比面部皮损更具治疗抵抗性。
评估 BF-200 ALA 联合红光光动力疗法（PDT）治疗四肢、躯干和颈部轻至重度 AK 的疗效和安全性。
本 3 期研究采用个体内设计，在德国 6 个中心纳入 50 例患者。每位患者最多接受 2 次靶向 PDT 治疗。记录临床终点和 1 年随访结果。
BF-200 ALA 组的总皮损清除率（86.0%比 32.9%；P<.0001）和每位患者每侧皮损的完全清除率（67.3%比 12.2%；P<.0001）均优于对照组。1 年时的总皮损复发率为 14.1%比 27.4%（BF-200 ALA 组比对照组；P=.0068）。BF-200 ALA/PDT 的美容效果更令患者满意。不良反应与已知的 BF-200 ALA/PDT 安全性特征一致。
严重皮损数量较少；样本量有限；AK 分布不均衡但具代表性。
BF-200 ALA 治疗四肢、躯干和颈部 AK 的皮损清除率显著高于对照组，且耐受性良好。
